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NASH Alone

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A Research Opportunity

Nonalcoholic steatohepatitis (NASH) is a common form of liver disease caused by fat cells stored in the liver and is accompanied by inflammation and liver cell damage. Over time, NASH can cause liver fibrosis (scarring) and may lead to cirrhosis or liver cancer. This study sponsored by Gilead (GS-US-454-6075) is researching whether the combination of a drug called semaglutide (SEMA) with investigational drugs cilofexor/firsocostat (CILO/FIR) can reverse liver damage, reduction in fibrosis, or NASH resolution in people with compensated cirrhosis due to NASH. If you are 18 to 80 years of age and have been diagnosed with NASH, you may qualify to participate in the study. SEMA has not been approved for this indication, CILO/FIR are investigational compounds. The safety and efficacy of these drugs has not been established for this use. There is no guarantee that these drugs will be approved by the US food and Drug Administration.

SEMA is designed to target adults with type 2 diabetes. The purpose of this Gilead study is to evaluate the safety and effectiveness of SEMA with investigational drugs, CILO/FIR, versus placebo in patients with NASH to see if it can cause fibrosis improvement. “Investigational” means that this drug has not yet been approved by the US Food and Drug Administration (FDA), and its use is being allowed for research purposes only.

If you qualify for the Gilead study and choose to participate, you will be enrolled for 72 weeks, during which you’ll be randomly assigned to receive either SEMA plus CILO/FIR or placebo. A placebo looks just like the investigational drug but contains no active medication. Neither you nor the study doctor will know which you are receiving until the end of the study, but in the case of an emergency, the study doctor can quickly find out.

All study-related office visits, medical procedures, laboratory tests, and study drug (either placebo or SEMA plus CILO/FIR) will be provided at no cost. Reimbursement for time and travel may also be available.

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Find a Participating Research Site

To get involved in this innovative opportunity, contact a participating Gilead study research site near you:

Greenwood, SC
Digestive Disease Research Center
316 West Alexander Avenue
Greenwood, SC 29646
864-867-1679
Florham Park, NJ
AIG Digestive Disease Research
195 Columbia Turnpike
Suite 115
Florham Park, NJ 07932
201-201-5267
Huntsville, AL
North Alabama Health Research
2009 Gallatin Street SW
Huntsville, AL 35801
256-529-4389
Little Rock, AR
ARcare Center for Clinical Research
8924 Kanis Road
Little Rock, AR 72205
501-214-0372
Long Beach, CA
Digestive Health Research of Southern California
3833 Worsham Avenue
Suite 300
Long Beach, CA 90808
562-542-1627
South Bend, IN
Digestive Research Alliance of Michiana
53830 Generations Drive
Suite 110
South Bend, IN 46635
574-393-9755
Wichita Falls, TX
Digestive Health Research of North Texas
1004 Brook Ave
Suite A
Wichita Falls, TX 76301
940-222-6675

About Clinical Research

Every day, clinical research uncovers new information about medical conditions and their treatments.

Volunteer involvement in research is key to the development and advancement of future therapies. Results collected from clinical studies have led to thousands of medications and devices becoming available to patients all over the world.

As a research participant, you will receive close care and monitoring from specialized medical professionals. Your participation may help advance the research of NASH and potential treatment options.

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If you have any questions, don’t hesitate to contact us.

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